The designation, granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K., is the first step toward inclusion in the Early Access to Medicines Scheme (EAMS), a program that allows patients with life-threatening conditions to try the latest, promising new medicines much earlier than they usually would be accessible.

PIM designation is granted to products meant to treat life-threatening diseases that have a high unmet medical need, are likely to offer major advantages over treatments available in the U.K., and whose benefits largely outweigh the risks. It was created as an early signal to companies that their product could be a candidate for the second phase of the EAMS program, in which the drug is made available to U.K. patients before the approval of a marketing authorization application.

“We are excited that the MHRA agrees that SGX301 meets the specified criteria for PIM designation,” Christopher J. Schaber, PhD, president and chief executive officer of Soligenix, said in a press release. “This is now the second of our programs to receive this important designation, with the first being SGX942 for the treatment of severe oral mucositis in head and neck cancer patients receiving chemo-radiation therapy. We look forward to working with the MHRA to advance both programs and leverage the potential benefits of the EAMS scheme to make these important products available to patients and physicians facing the challenges of CTCL and severe oral mucositis,” he said.

CTCL is a type of non-Hodgkin lymphoma caused by the expansion and migration of malignant T-cells in the skin. There is no cure for the disease, but SGX301 has shown promise in this patient population.

The treatment consists on the topical application of a potent photo-sensitizer, synthetic hypericin, that is activated by safe visible fluorescent light 16 to 24 hour later. When activated, hypericin has significant anti-proliferative effects on malignant T-cells from CTCL tumors. And, by avoiding ultraviolet A light exposure, like most photodynamic therapies, SGX301 avoids the risk of secondary cancers caused by DNA damage.

Data from a Phase 2 clinical trial in CTCL has shown a significant improvement with topical hypericin treatment compared to placebo. The company is now recruiting up to 120 CTCL patients into a Phase 3 multi-center, randomized, double-blind, placebo-controlled trial (NCT02448381) to further assess the safety and effectiveness of the treatment.

In January 2015, the U.S. Food and Drug Administration granted Fast Track designation to SGX301 for first-line treatment of CTCL.

Inês Martins holds a BSc in Cell and Molecular Biology from Universidade Nova de Lisboa and is currently finishing her PhD in Biomedical Sciences at Universidade de Lisboa. Her work has been focused on blood vessels and their role in both hematopoiesis and cancer development.

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